American Association for Clinical Chemistry
Improving healthcare through laboratory medicine
Regulations and Guidance

The CLIA'88 standards were promulgated on February 28, 1992.  These regulations cover all apsects of laboratory testing.  All laboratories in the United States, and those performing testing on specimens originating in the United States, must be in compliance with the standards. 

One of the requirements of the CLIA'88 regulations is that moderate and high complexity laboratories be periodically inspected.  To assist with its inspections, CMS has developed Interpretive Guidelines, which explain, in more detail, what a laboratory needs to do pass inspection and comply with the standards.  Both documents can be accessed through this site.

CLIA Regulation

CLIA Interpretive Guidelines